Action required: Pilot started 25/March/2021.

In March 2021 the European Commission, together with the EMA and Member States, committed to initiate a pilot to better understand the root causes of deferred market launches for centrally authorised products. The initiative has been launched with the engagement of future Marketing Authorisation Holders (MAHs).

The pilot’s overall objective is to “improve regulators’ knowledge of the planned marketing of centrally authorised medicinal products (CAPs) and on the reasons behind delayed market launch by engaging with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase.”

Why are Marketing Authorisation Holders not launching medicinal products European wide?

MAHs are not obliged to market a medicine in all EU countries even though they have achieved approval under the Centralised Procedure (CP). The reasons could be many, for example

  • National pricing and reimbursement policies
  • Market size and hence market potential
  • Organisation of health system including distribution of medicinal products
  • Administration burden
  • Operational limitations
  • Therapeutic area and availability of specialised staff and/or infrastructure

Which products are eligible for the pilot?

It is envisaged that only certain medicinal products will take part in this pilot. These products are orphan and oncology medicines in the context of newly submitted centralised applications, as well as centralised applications under assessment. Products are identified by their link to unmet needs and high public interest.

What method will be used?

Any MAH can take part in this pilot. MAHs will supply information about planned market launch and rollout of the medicinal product. Reasons for not bringing products to market or delayed launches will help to analyse and understand any possible impact, on both the MAH and member states.

MAHs should provide the following information:

  • Identification of the marketing authorisation applicant;
  • Identification of the medicinal product and its active substance;
  • Member States in which the company intends to market the product;
  • The envisioned timing of market launch per country;
  • Remarks on market launch intentions.

Templates for MAHs to notify any ‘Market Launch Intentions’ are provided by the EMA.

It is planned to run this pilot for a period of 18 months, beginning 25/March/2021. If you wish to take part, details can be found on the European Commission website here.

In summary

The aim of the pilot is to get a better understand of why MAHs that pursue the centralised procedure choose not to market their products in all European Union countries. Upon completion of the pilot, the data gathered will be analysed to see whether the reasons mentioned above (if any) are the contributing factors. Results and lessons learnt from this pilot will be published by the European Commission.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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